Effectiveness of autoHYpnosis in the Prevention of Anxiety During Radiotherapy of Head and Neck Tumors (HYMACO)

NCT04671485 | Completed

• 1 other identifier: 2020-A00813-36
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

Brief Summary

HYMACO is a monocentric, randomized comparative pilot study with a total duration of 25 months. The purpose of this study is to evaluate the effectiveness of autoHYpnosis by anchoring in the prevention of anxiety related to wearing the mask for radiotherapy of head and neck tumors. 60 patients will be randomized into 3 arms ARM A : Standard care ARM B : Autohypnosis ARM C : Musicotherapy This study is carried out during the first 5 radiotherapy sessions because this is decisive for the good progress of subsequent sessions

Conditions

Head and Neck Tumors

Keywords

Autohypnosis; Anxiety; 5 points Mask; Radiotherapy; Anchoring

Outcome Measures

Primary Outcomes (1)

• Anxiety

  Anxiety will be assessed by the maximum value obtained on the STAI form Y-A questionnaire (state anxiety) on the following 3 measurements: on the centering scanner, at the first and 5th radiotherapy session.

  5 weeks

Secondary Outcomes (6)

• Anxiety

  5 weeks

• Conduct of radiotherapy session

  5 weeks

• Time required by the hypnopractor for the hypnosis session

  1 hour

• Receptivity of patients to hypnosis

  5 weeks

• Assessment of the patient's feelings

  1 hour

Study Arms (3)

ARM A : standard care

ACTIVE COMPARATOR

standard care : Patient undergoing radiotherapy for head and neck tumor with a compression mask, and assessed as anxious about wearing this mask will have standard care

Other: Standard care

ARM B : standard care + Autohypnosis

ACTIVE COMPARATOR

In addition to the standard care, the patient will be called to learn autohypnosis during a specific consultation, with a radiotherapy manipulator trained to learn this technic. The patient will use this technic during the centering scanner and the first 5 radiotherapy sessions

Other: Standard care; Other: Autohypnosis

ARM C : standard care + Musicotherapy

ACTIVE COMPARATOR

In addition to the standard care, the patient will choose the music he want to listen from a music database (3 specific moods). The chosen music will be broadcast to the patient via a hi-fi system present in the treatment room during the centering scanner and for the first 5 radiotherapy sessions

Other: Standard care; Other: Musicotherapy

Interventions

Standard care OTHER

Patient undergoing radiotherapy for head and neck tumor with a compression mask, and assessed as anxious about wearing this mask will have standard care

ARM A : standard care; ARM B : standard care + Autohypnosis; ARM C : standard care + Musicotherapy

Autohypnosis OTHER

The patient will be called to learn autohypnosis during a specific consultation, with a radiotherapy manipulator trained to learn this technic. The patient will use this technic during the centering scanner and the first 5 radiotherapy sessions

ARM B : standard care + Autohypnosis

Musicotherapy OTHER

the patient will choose the music he want to listen from a music database (3 specific moods). The chosen music will be broadcast to the patient via a hi-fi system present in the treatment room during the centering scanner and for the first 5 radiotherapy sessions

ARM C : standard care + Musicotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \> or =18
• Patient to receive radiotherapy for a tumor of the head and neck, with a compression mask
• Patient who obtained a score equal to or greater than 56 on the STAI form Y-A questionnaire during the consultation with the radiotherapist before starting treatment
• Patient capable and willing to follow all study procedures in accordance with the protocol
• Patient who understood the study and gave informed consent
• Patient affiliated to a social security system

You may not qualify if:

• Contraindication to hypnosis: psychosis, schizophrenia
• Non-French speaking patient
• Significant hearing loss
• Pregnant woman, likely to be, or breastfeeding
• Persons deprived of their liberty or under guardianship (including guardianship)
• Inability to undergo medical monitoring of the trial for geographical, social or psychological reasons
• Patient who has already received radiotherapy to the head or neck with a compression mask

Sponsors & Collaborators

• Institut de Cancérologie de Lorraine: lead

Study Sites (2)

Institut de Cancérologie de Lorraine

Vandœuvre-lès-Nancy, 54519, France

Location

Institut de Cancérologie de Lorraine

Vandœuvre-lès-Nancy, Vandoeuvre lès Nancy, France

Location

MeSH Terms

Conditions

Head and Neck Neoplasms; Anxiety Disorders

Interventions

Standard of Care; Hypnosis

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Mental Disorders

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation; Mind-Body Therapies; Complementary Therapies; Therapeutics; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Rémi ETIENNE

  Institut de Cancérologie de Lorraine

  STUDY CHAIR

• RENARD Sophie, MD

  Institut de Cancérologie de Lorraine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 7, 2020
• First Posted: December 17, 2020
• Study Start: December 16, 2020
• Primary Completion: December 11, 2024
• Study Completion: February 5, 2025
• Last Updated: July 24, 2025

Record last verified: 2024-12

Locations

FR (2)